Legal Issues

A former farm worker named Enrique Rubio may just be the right “David” to take down “Goliath” chemical company Monsanto. Rubio filed suit against the manufacturer of Roundup® early last week, claiming that the company’s infamous herbicide is the cause of his bone cancer and inability to work.

Roundup’s® safety has been hotly debated for years among scientists, environmental activists and those concerned with human health. Rubio’s suit, if successful, may put an end to that debate once and for all by forcing Monsanto to provide proof that it knowingly withheld data on the true dangers of its flagship product.

The active ingredient in Roundup®, a nasty chemical called glyphosate, was discovered in 1970. Rubio’s suit states that [g”]lyphosate is a broad-spectrum, non-selective herbicide used in a wide variety of herbicidal products around the world. Plants treated with glyphosate translocate the systemic herbicide to their roots, shoot regions and fruit, where it interferes with the plant’s ability to form aromatic amino acids necessary for protein synthesis. Treated plants generally die within two to three days. Because plants absorb glyphosate, it cannot be completely removed by washing or peeling produce or by milling, baking, or brewing grains.”

Monsanto claimed glyphosate was “a technological breakthrough: it could kill almost every weed without causing harm either to people or to the environment.” However, that doesn’t seem to be the case. The World Health Organization (WHO) asserts that glyphosate is “a probable cause of cancer.”

Why would Monsanto take such a big risk? Money. The company needed a win in the industry in order to continue its “reputation and dominance in the marketplace. Largely due to the success of Roundup® sales, Monsanto’s agriculture division was out-performing its chemicals division’s operating income, and that gap increased yearly.” So, rather than go with a less toxic product, Monsanto sold humanity and the planet for its own bottom line.

Wait, a less toxic product? Is that possible? Indeed, it is possible and was possible from Day One. “The harm caused by [Monsanto’s] Roundup® products far outweighed their benefit. …Roundup® products were and are more dangerous than alternative products and {the company] could have designed its Roundup® products to make them less dangerous. Indeed, at the time that [Monsanto] designed its Roundup® products, the stat of the industry’s scientific knowledge was such that a less risky design or formulation was attainable.”

So basically, Monsanto decided it was better (for it) to release a carcinogenic product that it was to spend a bit more money taking the time to research a less harmful alternative. The sad thing is, knowing that its product was dangerous, Monsanto had to pull some serious strings to get it approved.

The EPA originally classified glyphosate as “possibly carcinogenic to humans” in 1985. However, “after pressure from Monsanto, including contrary studies it provided to the EPA, the EPA changed its classification to evidence of non-carcinogenicity in humans in 1991.”

The “contrary studies” involved two “independent” labs that willfully committed scientific fraud. The FDA inspected one lab, Industrial Bio-Test Laboratories (IBT), in 1976. That inspection uncovered “discrepancies between the raw data and the final report relating to the toxicological impacts of glyphosate.”

This prompted the EPA to do its own audit. The EPA found the same results. Moreover, one EPA reviewer said that, “after finding ‘routine falsification of data’ at IBT, that it was ‘hard to believe the scientific integrity of the studies when they said they took specimens of the uterus from male rabbits.’” Unsurprisingly, three of IBT’s top executives were convicted of fraud in 1983.

The other lab, Craven Laboratories, was hired by Monsanto to perform additional tests on glyphosate in 1991. “In that same year, the owner of Craven Laboratories and three of its employees were indicted, and later convicted, of fraudulent laboratory practices in the testing of pesticides and herbicides.”

According to Rubio’s complaint, “Despite the falsity of the tests that underlie its registration, within a few years of its launch, Monsanto was marketing Roundup® in 115 countries.” Nowadays, Monsanto’s glyphosate products can be found in 130 countries and are approved for use on over 100 different crops. If you think that you’re safe, think again.

“[Glyphosate products] are ubiquitous in the environment. Numerous studies confirm that glyphosate is found in rivers, streams, and groundwater in agricultural areas where Roundup® is used. It has been found in food, in the urine of agricultural workers, and even in the urine of urban dwellers who are not in direct contact with glyphosate.”

The New York Attorney General sued Monsanto in 1996 claiming its Roundup® advertising was “false and misleading.” The suit specifically challenged “Monsanto’s general representations that its spray-on glyphosate-based herbicides, including Roundup®, were ‘safer than table salt’ and ‘practically non-toxic’ to mammals, birds, and fish.”

Monsanto agreed, in 1996, to “cease and desist from publishing or broadcasting any advertisements [in New York].”

Various other governments have either severely restricted or outright banned the sale of Roundup®, including the Netherlands, Brazil, France, Bermuda, Sri Lanka and Columbia.

Indeed, this may be the beginning of the end for Monsanto and Roundup®. One can only hope that justice will prevail in Rubio’s case and the chemical giant will be forced to tell the truth and face the consequences.

Recently, Reuters reported that “Drug companies generally don’t disclose all the reasons new medicines fail to win U.S. marketing approval, even though regulators often reject treatments over concerns about safety or effectiveness”.

Reporter Lisa Rapaport quotes Dr. Peter Lurie, FDA associate commissioner for public health strategy and analysis, saying “‘Only a minority of the press releases clearly stated that receipt of a complete response letter meant that marketing could not commence, and most findings associating the drug with a higher mortality rate went unmentioned.’” (emphasis added)

In her report, Rapaport notes that Dr. Lurie reviewed announcements by pharmaceutical companies following FDA disapproval released between 2008 and 2013 and found that “About half of the time, the complete response letters cited shortcomings in both safety and effectiveness. Out of 191 concerns about effectiveness raised in the letters, drugmakers disclosed a total of 30 in press releases, while companies shared 22 of 150 safety concerns.

Roughly half of the letters asked for new clinical trials to study safety or effectiveness; and in 59 percent of these cases companies disclosed this in a press release.”

This practice makes intuitive sense for drug companies, however cynical it is to admit. Why would pharma companies want to disclose precisely how a proposed product failed to meet FDA safety and efficacy requirements?

This actually raises an important issue for the FDA: should all proposed pharmaceutical products, not only approved drugs and devices, be a part of public knowledge? Companies whose stock is traded on the open market are already required to detail drug rejections (as is noted in the aforementioned Reuters piece), but not all drug companies are publicly held. Privately-held pharmaceutical corporations will argue that disapproved compounds consist in proprietary knowledge, and they may be right, public health concerns aside.

It nonetheless still is important to consider drugs that “may have been,” (or rather, drugs that failed to surmount the ever-weakening FDA approval process). Many drugs sold in America are disapproved upon initial FDA review, and following simple adjustments to study design, methodology, or statistical rigour are approved without meaningful changes to drug design. That is, the method used to test a drug’s effectiveness or safety can be adjusted, and a disapproved drug is made legal, without change to a drug’s chemical design.

With attention paid to disapproved drugs through open communication between pharmaceutical companies, the FDA, and the American public, consumers can understand more completely whether substantive changes were made to a drug’s design between initial disapproval and subsequent approval.

By no means would I suggest it is necessary, or would even be helpful, that the American populous attempt a measure of biochemical or pharmacological scrutiny when reviewing the FDA’s news ticker. That is the task of science journalists and healthcare analysts. As long is information regarding drug disapproval is available in full, dissemination to the public is possible, and that is a good thing.

Recently, a craniofacial distraction implant by DePuy Orthopaedics was recalled. This device, called the Craniomaxillofacial (CMF) Distraction System, “is a modular family of internal distraction devices that are used to gradually lengthen the mandible body and ramus” and indicated as “a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or posttraumatic defects of the mandibular body and ramus, where gradual bone distraction is required,” for children less than one year old.

However, the FDA writes that “Infants are at the highest risk for injury if the device fails because sudden obstruction of the trachea can occur. This could lead to respiratory arrest, and result in death.” (emphasis added)

Again according to the FDA, “DePuy Synthes is recalling certain lots because the device may reverse direction and lose the desired distraction distance after surgery”, noting that “children or adults with the ability to maintain an open airway are at less risk for serious injury because failure of the device would not result in tracheal obstruction and could be medically reversible.”

Importantly, it is made clear that “In all patient populations, failure of the device may result in the need for surgical intervention to replace the failed device.”

To-date, fifteen people have been injured due to failure of the CMF Distraction System.

If you or a loved one used a CMF Distraction System and suffered injury as a result, you may be entitled to significant financial compensation through a CMF Distraction lawsuit. For a free, no-obligation case consultation, contact our team of CMF Distraction lawyers at the information provided below. We have the experience, resources, and skills required to win the justice you deserve. Call today and see how we can help.

What is federal preemption? It’s an easier concept to grasp than you might think.

Think back to when you were a kid, and you asked your mom if you could go to a party. She clearly said, “no.” You then went to ask your dad if you could go to the party, and he clearly said, “yes.” Since you were always taught that both parents ruled your actions, you figured as long as you had one parent’s approval to go the party, that was good enough, and you couldn’t get in trouble for going.

Wrong. That night, as you started to leave the house, your parents stopped you, forbidding you to go to the party after all. Angrily, they explained that since your mom had already determined that you could not go to the party, your dad’s permission was null and void. In other words, your mom’s rule wiped out or “preempted” your dad’s rule. Although you didn’t know it then, that night, you got your first lesson in the basic concept of federal preemption.

Federal preemption is a doctrine based on the Supremacy Clause of the United States Constitution, which states that federal law takes precedence over state law.

When state law and federal law conflict, federal law wipes out or “preempts,” state law, due to the Supremacy Clause of the Constitution. U.S. Const. art. VI., § 2. Specifically, the Supremacy Clause states, “the Laws of the United States …shall be the supreme law of the land …anything in the … laws of any state to the contrary notwithstanding.”

So, if federal law requires you to do something, and state law requires you do the opposite, which one wins? Due to federal preemption, federal law wins. For example, if, hypothetically, federal law requires you to paint your fence blue, and state law forbids you from painting your fence blue, federal law wins due to the Supremacy Clause of the Constitution. The federal law preempts the state law, and you would therefore be required to paint your fence blue.

In many recent cases involving prescription drugs, we have seen tension between federal law and state tort law. See, e.g.,PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011). The general pattern among these recent cases is as follows: State law requires all drug manufacturers—whether it be a brand-name manufacturer or a generic drug manufacturer—to design medications safely, and to provide adequate warning labels on all of their medications. In turn, if a drug manufacturer fails to safely design a medication or fails to provide an adequate warning label, and someone in harmed as a result, that person can sue the manufacturer under state tort law.

By direct contrast, federal law only requires brand-name manufacturers to design medications safely, and to provide adequate warning labels on all of their medications. Under federal law, the generic drug’s design and warning label must be identical to that of the brand-name version of the drug, no matter how unsafe or inadequate.

Therefore, if you are harmed by a generic version of a brand-name drug, state law automatically permits you to sue the manufacturer of the generic version, while federal law automatically forbids you from suing the manufacturer. Which one wins? Due to federal preemption, federal law wins.

The defendant companies are USPLabs, LLC (“USPLabs”) and General Nutrition Center Holdings Inc. (“GNC”). USPLabs sells a variety of energy and weight loss dietary supplements under the brand name of OxyElite Pro through GNC.

The complaint was filed in the U.S. District Court for the District of New Jersey. In it, Plaintiff Barot says he bought and used OxyElite Pro supplements while living in New Jersey between March 2010 and October 2011. He says he bought the product at a GNC store. Barot says OxyElite Pro was sold in New Jersey between January 2008 and November 2013.

In April 2012, the Food and Drug Administration warned USPLabs about the use of a dangerous stimulant called dimethylamylamine (“DMMA”) in its products. A class-action complaint followed and was resolved by a settlement agreement. Hogan v. USPLabs LLC, No. BC486925 (Cal. Super. Ct., L.A. County).

However, during and subsequent to Hogan v. USPLabs, LLC, Defendant USPLabs contained and or included another dangerous ingredient in OxyElite Pro called, Aegeline. Public health officials are currently investigating severe illnesses allegedly connected to Aegeline, including liver disease and hepatitis.

Plaintiff Barot points to medical records submitted to the FDA by the Hawaii Department of Health in which patients who used OxyElite Pro became severely ill. The complaint states that the use of the product was the only common factor among the patients and many became well again after stopping its use. Therefore, the complaint argues, the likelihood that OxyElite Pro caused the illnesses is strong.

While some consumers were lucky enough to get well after they ceased ingesting the dietary supplement, for others, the damage had already been done. Several patients sustained liver injuries that required transplantation. Tragically, one patient died before a transplant could be performed. As of February, OxyElite Pro has been linked to 97 cases of hepatitis.

On Oct. 11, 2013, the FDA issued a warning to USPLabs to stop distribution of all products containing aegeline. The company conducted a voluntary recall about one month later, but Barot says it failed to provide any notice to consumers.

Specifically, Barot says he and other potential class members suffered economic damage in buying USPLabs’ products, which they would not have taken had they known of aegeline’s potential adverse effects. He also alleges that inadequate labeling on the product constituted an unfair trade practice because the ingredients were unfit for safe use and that the defendant companies were unjustly enriched at the expense of consumers’ health.

We are grateful for the opportunity to submit comments in support of the Food and Drug Administration’s (FDA) proposed rule entitled, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985).

Currently, a generic drug’s design and warning label must identically match that of the name-brand version of the drug. In turn, generic manufacturers are prohibited from making any material changes to the drug’s design or warning label. As a result, generic manufacturers cannot be sued for providing consumers with unsafe medications.

It is outrageous that a generic drug manufacturer can know that a warning label is inadequate, sell the drug anyway, and escape all liability. We believe that the proposed rule, which holds both generic and brand-name manufacturers responsible for informing the public about known risks of their medications, will promote health, safety, and equality.

The Fourteenth Amendment Supports the Proposed Rule

The Equal Protection Clause of the Fourteenth Amendment to the United States Constitution prohibits states from discriminating between the “poor” and the “rich.” A state can no more discriminate on account of financial status than on account of religion, race, or color. See Griffin v. Illinois, 351 U.S. 12, 17, 76 S. Ct. 585, 590, 100 L. Ed. 891 (1956). See also U.S.C.A.Const. Amend. 14; S.H.A.Ill.Const. art. 2, § 19.

The current law, which holds manufacturers of generic drugs to a lesser legal standard than their brand-name counterparts, essentially discriminates between the poor and the rich. After all, the only difference between brand-name drugs and their generic equivalents is price. Generic brands are often significantly less expensive than their brand-name counterparts.

In fact, generic drugs were originally made in an effort to ensure that effective and safe drugs were widely and inexpensively available to citizens who could not otherwise afford medications. Thus, people who are less financially well-off are the ones who were, and are, specifically intended to purchase generic drugs. In other words, poor people buy generic brands.

If someone takes a brand-name medication and develops a disease as a result of taking the brand-name medication, she can sue the company that manufactured the drug. Those who can afford the brand-name drug in the first place are the ones—and only ones—who are allowed to be compensated for injuries sustained from ingesting an unsafe drug.

On the other hand, if a financially less-fortunate individual goes to the pharmacy and inevitably opts for the cheaper generic version of the drug, and develops the same disease or adverse side effect, she cannot sue the generic manufacturer. Instead, she is left to incur medical expenses for the harm she suffers as a result of consuming the unsafe drug, even though she is just as innocent as the financially well-off consumer.

It is heartbreaking that the very people who cannot afford brand-name drugs in the first place are singled out and deprived of the right to be justly compensated. The result is that “rich” people are protected under the current federal law, while “poor” people are not. The proposed rule, by contrast, which protects consumers of brand-name drugs as well as consumers of generic equivalents, works to conform to the Equal Protection Clause of the Fourteenth Amendment.

The Proposed Rule Will Save Courts Time and Resources

We had mixed feelings with regard to a recent order issued by a Federal District Judge in Illinois in the case of Dolin v. Smithkline Beecham Corporation d/b/a Glaxosmithkline, which found that, under Illinois law, a brand-name manufacturer owes a duty to consumers of generic versions of its drugs. The ruling was as good as anyone could hope for under the current law.

The plaintiff in the case is a woman whose husband committed suicide after taking a medication called, paroxetine, which is manufactured by Mylan, Inc. Paroxetine is the generic version of the brand-name drug, Paxil, which is owned and manufactured by GlaxoSmithKline (“GSK”). The plaintiff brought a wrongful death action against both GSK and Mylan.

The Judge had no choice but to find that Mylan could not be held liable, because federal law preempts claims against manufacturers of generic versions of brand-name drugs. However, creatively, the Judge found that the brand-name manufacturer could be held liable even though it was not the company that actually manufactured the pill that resulted in the plaintiff’s husband’s fatality.

We are pleased because at least the Judge found that the plaintiff could be compensated by one of the negligent companies. However, we believe that the Judge had to go around his hand just to get to his thumb. The Judge issued an intricate 26 page opinion, exploring vague precedent to “get around” the law that states generic manufacturers cannot be sued. It seems a great deal of the court’s time and resources were wasted as a result.

We believe that the proposed rule, which holds both generic and brand-name manufacturers responsible for informing the public about known risks of their medications, will save the courts time and resources because judges will have a clear, set standard.

Conclusion

Thank you again for the opportunity to submit comments in support of the Food and Drug Administration’s (FDA) proposed rule entitled, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985). As explained above, in addition to saving the courts valuable time and resources, we believe the new rule will promote health, safety, and equality in our society.

We are pleased with a recent order issued by a Federal District Judge in Illinois, which found that, under Illinois law, a brand-name manufacturer owes a duty to consumers of generic versions of its drugs.

The plaintiff in the case is a woman whose husband committed suicide after taking a medication called, paroxetine, which is manufactured by Mylan, Inc. Paroxetine is the generic version of the brand-name drug, Paxil, which is owned and manufactured by GlaxoSmithKline (“GSK”). The plaintiff brought a wrongful death action against both GSK and Mylan. Among other claims, the plaintiff brought negligence claims against both defendants.

The plaintiff’s husband’s doctor wrote him a prescription for Paxil to treat work-related anxiety. However, his prescription was ultimately filled with the generic version, paroxetine. Six days after beginning to take paroxetine, the husband purposefully leaped in front of a train to his death. Blood tests taken with his biopsy were positive for paroxetine.

According to the complaint, the plaintiff and her husband were financially secure, owned their home outright, and had no pressing debts. What caused such a drastic change in the husband’s mind that he would take his own life within six days? He took paroxetine. Besides work-related stress, it seems that, up until the time the husband took paroxetine, he enjoyed tranquility in his life, and never showed any signs of suicide whatsoever.

The paroxetine label in existence at the time of the husband’s death did not warn of the medication’s association with increased risk of suicidal behavior in adults. Instead, the label specifically stated the exact opposite—that no risk of suicide existed beyond the age of 24. However, the plaintiff asserts that the defendant companies had concrete knowledge that paroxetine use carried a substantial risk of suicidal behavior in adults above the age of 24, and yet promoted the medication as safe and effective.

The issue is whether either of the defendant companies can be held liable for damages caused by the medication that resulted in the plaintiff’s husband’s fatality. Here lies the difficult “catch” for the plaintiff in the case at hand, and other similarly situated plaintiffs: GSK argues that because it did not manufacture the actual pill that the husband ingested, it cannot be held responsible, and is entitled to judgment as a matter of law. Mylan, on the other hand, too, argues that it cannot be held liable, because federal law preempts claims against manufacturers of generic versions of brand-name drugs.

Although absurd, Mylan is correct. Due to a ruling by the United States Supreme Court, if you are harmed by a generic version of a brand-name drug, you cannot sue the manufacturer of the generic version. This is because, under federal law, the generic drug’s design and warning label must be identical to that of the name-brand version of the drug. As the Supreme Court recently summarized:

“First, the proposed generic drug must be chemically equivalent to the approved brand-name drug: it must have the same “active ingredient” or “active ingredients,” “route of administration,” “dosage form,” and “strength” as its brand-name counterpart. 21 U.S.C. §§ 355(j)(2)(A)(ii) and (iii). Second, a proposed generic must be “bioequivalent” to an approved brand-name drug. § 355(j)(2)(A)(iv). That is, it must have the same “rate and extent of absorption” as the brand-name drug. § 355(j)(8)(B). Third, the generic drug manufacturer must show that “the labeling proposed for the new drug is the same as the labeling approved for the [approved brand-name] drug.” § 355(j)(2)(A)(v). Mutual Pharmaceutical Co., Inc. v. Bartlett, 133 S.Ct. 2466, 2471 (2013).

In accordance with the above ruling, the Illinois Federal Judge in the case at hand had no choice but to grant Mylan’s motion to dismiss, concluding that, “with respect to any alleged defects in connection with a generic drug’s warning label, a generic manufacturer’s hands are simply tied.” With regard to Mylan, the generic manufacturer, federal law simply preempted the plaintiff’s claims. As a result, the plaintiff’s only hope for any sort of compensation hinged on whether the court found that GSK, the brand-name manufacturer, was somehow liable.

Fortunately—and a bit creatively—the court found that, under Illinois law, a brand-name manufacturer owes a duty to consumers of generic versions of its drugs, and thereby denied GSK’s motion for summary judgment with regard to the plaintiff’s negligence claims.

In order to constitute a common law negligence claim, a plaintiff must allege facts establishing (1) a duty of care owed by the defendant to the plaintiff; (2) a breach of that duty; and (3) an injury (4) proximately caused by the breach. Simpkins v. CSX Transportation, Inc., 965 N.E.2d 1092, 1096 (Ill. 2012). The court found that GSK did indeed owe a duty of care to the plaintiff and her husband, stating:

“[I]t is well understood that any generic manufacturer would be required by law to use GSK’s design and warning label, and that any defects later discovered could only be cured by GSK. Under such circumstances, it was entirely foreseeable that negligence on the part of GSK with respect to paroxetine’s design and warning label could result in injury to a consumer ingesting a subsequent generic version of the drug. Continuing with the duty inquiry described above, and again construing all facts and drawing all reasonable inferences in Plaintiff’s favor, GSK has not shown why the likelihood of injury was so remote as to undo GSK’s duty of care. The principal distinction GSK insists upon – that Mr. Dolin did not ingest a product that GSK manufactured – does not lessen the likelihood that GSK’s allegedly tortious conduct would lead to Plaintiff’s injury. Under the regulatory scheme created by the Hatch-Waxman Act, whether a consumer ingests the name-brand or generic version of a given drug is immaterial as to the likelihood that negligence in the design or warning label of that drug will cause injury.”

As the patent holder, GSK was responsible for paroxetine’s design and warning label. Under the Hatch-Waxman Act, only GSK was legally permitted to cure any warning label defects. We applaud the court for finding that a brand-name manufacturer owes a duty to a patient who fills his or her prescriptions with the generic equivalent of the medication. The plaintiff in this case raised a genuine issue of material fact as to whether GSK, through negligent conduct, breached this duty, proximately causing her injuries.

It is our firm’s stance that a patient should be able to recover for injuries obtained as a result of taking an unsafe medication—whether the medication is the brand-name version or a generic equivalent. We hope that other courts will follow the Illinois Federal court’s example and ensure that plaintiffs harmed by generic versions of medications have an avenue by which to be compensated.

Currently, at least 97 people have suffered severe hepatitis in connection with OxyElite Pro, and one person has died. The first reports of liver damage linked to OxyElite Pro came to light in May 2013, but the FDA was not aware of this until September of that year. Several months later, the manufacturer of OxyElite, USPLabs, issued a voluntary recall.

Scientists now believe that the questionable OxyElite ingredient, aegeline, is responsible for these cases of hepatitis, and the FDA has ordered USPLabs to discontinue its use.

Dr. Pieter Cohen of Harvard University published an article in The New England Journal of Medicine on this topic topic and explains that the hepatitis cases linked to OxyElite Pro are merely emblematic of a larger problem: the safety and efficacy of dietary supplements are not regulated by the FDA before products hit the shelves.

Cohen writes “The FDA’s delayed response — with its life-threatening consequences — is attributable to our woefully inadequate system for monitoring supplement safety. Americans spend more than $32 billion a year on more than 85,000 different combinations of vitamins, minerals, botanicals, amino acids, probiotics, and other supplement ingredients. Unlike prescription medications, supplements do not require premarketing approval before they reach store shelves. Under the Dietary Supplement Health and Education Act of 1994, anything labeled as a dietary supplement is assumed to be safe until proven otherwise. The FDA is charged with the unenviable task of identifying and removing dangerous supplements only after they have caused harm.”

He explains that in 2013 alone, his colleagues and FDA researchers identified two novel analogues of methamphetamine present in products currently available to consumers. One analogue was present in a sports drink, and the other analogue was present in nine dietary supplements. By law, none of these products were to be reviewed ad hoc by the FDA, a loophole in effect making lab animals out of consumers.

Though a US Senate bill sponsored by Dick Durbin (D-IL) and Richard Blumenthal (D-CT) is currently under review by committee that would ensure proper labeling of “vitamins, minerals, botanicals, probiotics, and other supplement ingredients,” Dr. Cohen states that this “would not improve the FDA’s ability to detect and remove dangerous supplements from store shelves.”

What is required is a more broadened reform of the approval processes for dietary supplements and other such products. It seems clear and obvious that anything consumed in our country should undergo rigorous testing before it becomes available on the market, particularly if a product advertises health benefits. While this could lengthen the time it takes before products may be sold and increase costs, any financial burden or wait time would be well worth the benefit of a more protected America.

Generic brands. Knock-offs. It’s probably safe to assume that all of us have used one at some point or another. Many of us use them on a regular basis. Why? Because, usually, a generic brand product is pretty much the same thing as its brand-name equivalent. The main (and sometimes, only) difference is price. Generic brands are often significantly less expensive than their brand-name counterparts. This holds true in many aspects of life—clothes, shoes, accessories, groceries, and medications.

But in addition to cost, when it comes to medications specifically, there is one other significant difference between generic brands and brand-name companies: Legally, manufacturers of generic brand drugs are held to a lesser standard. For example, if you develop a disease as a result of taking a brand-name medication, you can sue the company that manufactured the drug; but on the other hand, if you go to the pharmacy and opt for the cheaper generic version of the drug, and develop the same disease or adverse side effect, you cannot sue the generic manufacturer.

The above logic seems counterintuitive. Yet, in a 5-4 decision last year, the Supreme Court ruled that generic drug companies cannot be held liable for medication design defects. The rationale goes something like this: Federal law requires generic companies to have a warning label that is identical to that of the brand-name drug. Therefore, if a warning label on a generic drug contains false information, the generic drug company claims it isn’t responsible because it is copying the brand-name label. The Supreme Court bought that argument, although the dissenting opinion describes the result as “absurd.” And it is absurd that a generic drug manufacturer can know that the warning label is inadequate, sell the drug, and escape all liability.

Generic versions of drugs are beneficial to society in that they give patients the option to buy medications at a low cost, when they would otherwise simply go without filling their prescriptions at all. However, until manufacturers of generic brand drugs are held to the same legal standard as their brand-name competitors, patients are not truly protected. After all, if one is harmed by a generic drug, the cost savings of a generic drug disappears if consumers or taxpayers have to foot the bill for treatments of undisclosed-but-known side effects.

A recent article in the Los Angeles Times discusses industry pushback against proposed federal legislation that would allow the manufacturers of generic pharmaceutical drugs the ability to “inform people about all known health risks” associated with various drugs produced. The Generic Pharmaceutical Association was quoted saying that the new regulations “would create ‘dangerous confusion’ and have ‘harmful consequences for patients.’”

This sentiment comes as a result of a report by independent consulting firm Matrix Global Advisors stating “the rule change would needlessly complicate the market and add $4 billion a year to already bloated healthcare costs.”

Alex Brill, lead author of the aforementioned report, states that this increase in cost would come as “‘Higher insurance premiums, self-insurance costs and reserve spending on product liability will likely force generic drug manufacturers to raise prices’” in an interview with the LA Times. That same LA Times piece also notes that the Matrix report was “sponsored” by none other than the Generic Pharmaceutical Association.

Obviously, the generic pharmaceutical industry wants to keep its costs down, but it is sad that this end seems valued over consumer safety. As it currently stands, the manufacturers of brand name drugs are required by the FDA to inform the public of newly-discovered hazards related to their medications. This does not apply to generic drugs manufacturers.

LA Times states that in response to this most recent ruling, the FDA has chosen to “empower generic makers to update their warning labels any time new risks become known, rather than wait for federal authorities to require a change.”

The reason that generics manufacturers are opposed to this change is that when label changes weren’t under their purview, companies could sit on data showing a health risk associated with their products without the legal obligation to act. Now, these companies would be obligated to make timely, effective label changes, which could hurt sales of the drug in question — as it should.

About this Blog

This blog chronicles legal and scientific news relating to personal injuries caused by defective drugs and medical devices. It is published by injury lawyer Justinian C. Lane, an attorney who takes a personal interest in each of his clients’ cases.